The Effects of Inhaled Budesonide-formoterol-glycopyrronium in Moderate-to-severe COPD
NCT ID: NCT04675463
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-12-30
2023-06-30
Brief Summary
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There are still some unmet medical needs and evidence gaps in COPD therapy, such as could BGF Inhalation Aerosphere reverse the disease progression such like airway-remodelling? Could BGF Inhalation Aerosphere reduce inflammation in small airways? Before differences proven between medication groups, pilot study is needed.
This 52 weeks, Single-center, prospective, interventional pilot study could help discovering intervention effect of BGF and GFF on small airways through OCT measurement, which would show outcome of AEROSPHERE™ Delivery Technology on COPD patients.
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Budesonide/Glycopyrronium/Formoterol arm
52 weeks treatment
BGF Inhalation Aerosphere
Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time
Glycopyrronium/Formoterol arm
52 weeks treatment
GFF Inhalation Aerosphere
Glycopyrronium/Formoterol: 7.2/4.8 per puff, twice daily with two puffs per time
Interventions
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BGF Inhalation Aerosphere
Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time
GFF Inhalation Aerosphere
Glycopyrronium/Formoterol: 7.2/4.8 per puff, twice daily with two puffs per time
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* With capability of receiving and participating in study related auxiliary examinations.
* Age: 40-80 yrs, both male and female, with or without smoking history, receiving treatment in community hospitals or outpatient department in general hospitals
* GOLD Stage II-III COPD: FEV1/FVC\<70% and FEV1 45-80% predicted (about 1/3 subjects in 45%-50%), measured 20min after 400μg salbutamol inhalation
* With stable COPD (no COPD exacerbation during the latest 4 weeks prior to the recruitment) and irregular use of inhalation therapy, or regular use of inhalation therapy but no more than 2 weeks. Subject is willing and, in the opinion of the investigator, able to adjust current COPD therapy, as required by the protocol.
Exclusion Criteria
* Significant diseases or conditions other than COPD. A significant disease or condition is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study
* Patients with clinical diagnosis of lung cancer, bronchiectasis, pneumoconiosis, or other single restricted ventilation.
* Severe cardiovascular, neural, hepatic, renal and hematologic diseases or malignancies that may interfere with the operation of the study.
* Patients with prostatic hyperplasia or bladder neck obstruction with significant symptoms, or narrow angle glaucoma
* Patients have a current and history diagnosis of asthma, or who have a blood eosinophil count ≥600/mm3 (0.6×109/L).
* Patients with active pulmonary tuberculosis
* Patients with life-threatening pulmonary embolism, α1-antitrypsin deficiency, or cystic fibrosis
* History of pneumonectomy.
* COPD exacerbation in 4 weeks prior to the first visit (V1), or hospitalization and/or antibiotic application and/or oral or intravenous glucocorticosteroids application is required during screening stage.
* Long-term oxygen therapy, frequent use of glucocorticosteroids orally or intravenously (prednisone\>10mg/d), or long-term use of antibiotics.
* Women who are pregnant or lactating or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
* Planned hospitalization or blood donation during the trial.
* Known hypersensitivity or intolerance to trial drugs.
* History of chronic alcohol or drug abuse, or any other conditions that may impact compliance.
* With contraindications to undergo bronchoscopy.
40 Years
80 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
ShiYue Li
OTHER
Responsible Party
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ShiYue Li
Professor
Principal Investigators
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Shiyue Li, Doctor
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Institute of Respiratory Disease
Locations
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Guangzhou Institute of Respiratory Diseases
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Shiyue Li, Professor
Role: primary
Ziqing Zhou, Doctor
Role: backup
Other Identifiers
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OCT-19-20271
Identifier Type: -
Identifier Source: org_study_id